Male homosexuals are at risk for hepatitis A virus (HAV) infection, and HAV vaccination has been recommended to prevent HAV infection in male homosexuals. HIV infection may impair serological responses to HAV vaccination in HIV-infected patients. The investigators hypothesize that 3 doses of HAV vaccine will improve serological responses to HAV vaccine in HIV-infected patients.

HIV-uninfected male homosexuals will be provided 2 doses of HAV vaccine, which will be administered at baseline and 6th month of follow-up.

Biological: Hepatitis A vaccine

2 or 3 doses of hepatitis A vaccine to HIV-infected male homosexuals and 2 doses of hepatitis A vaccine to HIV-uninfected male homosexuals.

Other Names:

HAVRIX (1440 ELISA unit)per dose.

MSM

Active Comparator: HIV-infected male homosexuals, group1

HIV-infected male homosexuals will be provided 3 doses of HAV vaccine, which will be administered at baseline, 1st, and 6th month of follow-up.

Biological: Hepatitis A vaccine

2 or 3 doses of hepatitis A vaccine to HIV-infected male homosexuals and 2 doses of hepatitis A vaccine to HIV-uninfected male homosexuals.

Other Names:

HAVRIX (1440 ELISA unit)per dose.

MSM

Active Comparator: HIV-infected male homosexuals, group 2

HIV-infected male homosexuals will be provided 2 doses of hepatitis A vaccine, which will be administered at baseline and 6th month of follow-up.

Biological: Hepatitis A vaccine

2 or 3 doses of hepatitis A vaccine to HIV-infected male homosexuals and 2 doses of hepatitis A vaccine to HIV-uninfected male homosexuals.

Other Names:

HAVRIX (1440 ELISA unit)per dose.

MSM

Detailed Description:

In this study, we aim to compare the serological responses to HAV vaccination between HIV-infected patients who receive 2 doses or 3 doses of HAV vaccine and HIV-uninfected persons who receive 2 doses of HAV vaccine. Persons who identify themselves as male homosexuals aged younger than 40 years and are seronegative for hepatitis A virus will be enrolled. HAV vaccination will be provided free-of-charge. HIV-uninfected persons will receive 2 doses of HAV vaccine that will be administered at baseline and 6 months after the first dose, while HIV-infected patients will be given 2 doses or 3 doses of HAV vaccine; for those who choose to receive 3 doses, a second dose will be given 1 month after the first dose. A longitudinal follow-up of serological responses will be conducted to assess the effectiveness of HAV vaccination; HAV IgG will be determined at 6 months after the first dose of HAV vaccination(before the administration of the second dose), 12 months and 18 months after the first dose of HAV vaccination .

Eligibility

Ages Eligible for Study:

18 Years to 40 Years (Adult)

Genders Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Age between 18~40-years-old

Homosexuals

Exclusion Criteria:

Presence of symptoms or signs suggestive of active infection

Allergy to vaccination

Failure to provide written informed consent

Use of immunosuppressive or immunomodulating agents or chemotherapy

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102296

Locations

Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Principal Investigator:

Chien-Ching Hung, MD

Division of Infectious Disease, Department of Internal Medicine, National Taiwan University Hopsital